Optical fiber auxiliary system for blood vessel puncture of children and multiple parts

Abstract

The invention provides an optical fiber auxiliary system for blood vessel puncture of children and multiple parts. The optical fiber auxiliary system comprises an optical fiber puncture needle assembly, a photoelectric detection device and a signal processing unit, the optical fiber puncture needle assembly is provided with a replaceable large-size needle assembly for adults and a small-size needle assembly for children; and the photoelectric detection device has an adjustable signal judgment threshold value and a mode selection function, so that corresponding detection parameters can be selected according to the specification of the connected needle assembly. According to an optical fiber puncture system optimization scheme adaptive to children and multiple parts, through finer optical fibers and needles, more intelligent algorithm threshold adjustment and diversified needle assembly form design, the application range of the optical fiber puncture auxiliary technology is expanded, it is guaranteed that different crowds can safely benefit, and the optical fiber puncture auxiliary system has remarkable clinical popularization significance.

Description

Technical Field

[0001] This invention relates to the fields of biomedical engineering and clinical puncture assistance technology, and in particular to a fiber optic assist system for pediatric and multi-site vascular puncture. Background Technology

[0002] Establishing intravenous access for infants and other pediatric patients is a highly technical clinical procedure, and conventional adult puncture techniques have a low success rate in children. Firstly, children's blood vessels are thin and delicate, while adult puncture needles and optical fibers are relatively large in diameter, potentially increasing puncture trauma and pain. Children also have smaller circulating blood volumes and weaker peripheral perfusion, resulting in lower pulse oxygenation amplitudes; using adult thresholds can easily lead to missed punctures. Secondly, vascular conditions vary greatly at different puncture sites. For example, veins in the scalp of newborns and superficial veins in the limbs are shallow and prone to slippage, and the commonly used instruments differ from those used for central venous puncture (e.g., butterfly needles are commonly used for scalp veins). Traditional methods rely heavily on repeated attempts and the operator's experience, increasing the pain and risks for the child due to multiple punctures.

[0003] In existing technologies, there are very few puncture assistance devices specifically designed for children. Medical devices are typically designed primarily for adults, then scaled down for children. Fiber optic sensing technology offers a new approach—using optical signals to assist in determining whether a puncture was successful. The aforementioned fiber optic puncture assistance system has shown good results in adult deep vein punctures, but its direct application to pediatric patients or punctures at special sites may face some challenges. Simply scaling down the size is insufficient; adjustments to signal processing algorithms and changes in usage methods are also necessary. For example, children's arterial blood oxygen levels are generally slightly lower than adults' (especially newborns), and venous blood oxygen levels may also differ; children have faster heart rates and shorter pulse wave cycles, requiring higher sampling rates; and when children are uncooperative, there are more motion-related spurious signals, necessitating more intelligent algorithms. Furthermore, regarding multi-site adaptation, currently no puncture assistance system can simultaneously accommodate multiple sites, including central veins, great saphenous veins, and scalp veins. Under these circumstances, even if fiber optic sensors are applied to pediatric punctures, if the algorithm is not optimized, problems such as low signal-to-noise ratio and high false positive rates may occur. Therefore, it is necessary to develop specialized puncture aids and algorithms for children and multi-site scenarios to ensure the reliable application of this technology in a wider range of clinical settings. Summary of the Invention

[0004] The present invention aims to solve at least one of the technical problems existing in the prior art, and proposes a fiber optic assisted system for pediatric and multi-site vascular puncture.

[0005] This invention provides a fiber optic-assisted system for pediatric and multi-site vascular puncture, comprising a fiber optic puncture needle assembly, a photoelectric detection device, and a signal processing unit; The fiber optic puncture needle assembly has a replaceable large-size needle assembly for adults and a small-size needle assembly for children; The photoelectric detection device has an adjustable signal judgment threshold and mode selection function, so as to select the corresponding detection parameters according to the specifications of the connected needle assembly.

[0006] In some possible embodiments, the fiber diameter in the pediatric small-sized needle assembly ranges from 50 to 100 micrometers, and the needle tube size ranges from 24G to 26G, to reduce puncture damage to children's blood vessels.

[0007] In some possible embodiments, the signal processing unit is used to select and adjust the parameters of the blood oxygen saturation determination algorithm according to a preset mode. Specifically, in the pediatric mode, the pulse amplitude threshold and the lower limit of the normal range of blood oxygen saturation are reduced to adapt to the weaker peripheral perfusion and potentially lower venous blood oxygen levels in children.

[0008] In some possible embodiments, the signal processing unit employs high-speed, high-gain data amplification and filtering algorithms in the child mode to extract high heart rate, low amplitude pulse signals, while employing intelligent discrimination algorithms to avoid false signals triggered by the child's agitation and misjudgment.

[0009] In some possible embodiments, the signal processing unit is further configured to: Based on the shaking signal of the needle assembly, if it exceeds the preset threshold, the determination of the puncture site of the needle assembly will be temporarily suspended or the criterion threshold of the target puncture site will be increased to prevent false signals.

[0010] In some possible embodiments, the fiber optic puncture needle assembly includes straight needle type and butterfly wing needle type; The straight needle type is used for routine central venous puncture, while the butterfly needle type is used for scalp vein or superficial small vein puncture, to meet the operational needs of different sites.

[0011] In some possible embodiments, population-adaptive structures designed for different puncture sites on the scalp and limbs include flexible fixation wings and adjustable-angle needle holders to ensure that the fiber optic puncture needle is stable and reliable when used in special sites and that patients are comfortable.

[0012] In some possible embodiments, the fiber optic puncture needle assembly is connected to the photoelectric detection device via a standardized interface, and the photoelectric detection device can automatically identify the needle assembly type or manually set the corresponding mode via a mode selection switch.

[0013] In some possible embodiments, when a child mode is detected, the photodetector increases the LED drive current, thereby increasing the emitted light intensity.

[0014] In some possible embodiments, the fiber optic sensor front end of the pediatric small-sized needle assembly is encapsulated with an added fiber end-face reflective film or microlens to enhance the signal and improve the efficiency of light signal acquisition in microvascular vessels.

[0015] The fiber optic-assisted system for pediatric and multi-site venous puncture embodiments of this invention, through multi-dimensional hardware and software adjustments, makes the fiber optic puncture system a truly broad-spectrum medical tool. Regardless of the patient's age or the depth of the blood vessels, the system can function effectively simply by changing the appropriate needle components and adjusting the mode. This greatly enhances the practical value of this technology, especially in pediatrics and complex venous punctures, where it will become a powerful auxiliary tool.

[0016] In summary, the optimized fiber optic puncture system of this invention for children and multiple sites expands the applicability of fiber optic puncture-assisted technology by using thinner optical fibers and needles, more intelligent algorithm threshold adjustment, and diversified needle component morphology designs, ensuring that different groups of people can safely benefit from it, and has significant clinical application value. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the structure of a fiber optic-assisted system for pediatric and multi-site vascular puncture according to an embodiment of the present invention. Detailed Implementation

[0018] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] Figure 1 This is a schematic diagram of the structure of a fiber optic-assisted system for pediatric and multi-site vascular puncture according to an embodiment of the present invention.

[0020] like Figure 1 As shown, this embodiment of the invention relates to a fiber optic assisted system for vascular puncture in children and at multiple sites, including a fiber optic puncture needle assembly, a photoelectric detection device 3, and a signal processing unit. The fiber optic puncture needle assembly has a replaceable large-size adult needle assembly 1 and a small-size pediatric needle assembly 2; the photoelectric detection device 3 has adjustable signal determination thresholds and mode selection functions to select appropriate detection parameters according to the specifications of the connected needle assembly. For example, a knob 4 can be provided on the photoelectric detection device 3 to adjust the signal determination threshold and select the mode.

[0021] The fiber optic-assisted system for pediatric and multi-site venous puncture embodiments of this invention, through multi-dimensional hardware and software adjustments, makes the fiber optic puncture system a truly broad-spectrum medical tool. Regardless of the patient's age or the depth of the blood vessels, the system can function effectively simply by changing the appropriate needle components and adjusting the mode. This greatly enhances the practical value of this technology, especially in pediatrics and complex venous punctures, where it will become a powerful auxiliary tool.

[0022] In summary, the optimized fiber optic puncture system of this invention for children and multiple sites expands the applicability of fiber optic puncture-assisted technology by using thinner optical fibers and needles, more intelligent algorithm threshold adjustment, and diversified needle component morphology designs, ensuring that different groups of people can safely benefit from it, and has significant clinical application value.

[0023] In some embodiments, such as Figure 1 As shown, the optical fiber diameter in the pediatric small-sized needle assembly 2 ranges from 50 to 100 micrometers, and the needle tube size ranges from 24G to 26G, in order to reduce puncture damage to children's blood vessels.

[0024] Specifically, such as Figure 1 As shown, in this embodiment, considering the thin and fragile nature of children's veins, smaller diameter optical fibers and finer needles are used to reduce puncture wounds and foreign body sensation. For example, the optical fiber diameter used in the adult system is approximately 200 micrometers, while the pediatric system uses an ultra-fine optical fiber of 50–100 micrometers; the puncture needle is changed from 18–20G for adults to 24–26G or even finer. Although the light-gathering area is reduced by the finer optical fiber, the signal enhancement measures and algorithm adjustments described later will compensate for this. In addition, a softer optical fiber material is chosen, such as highly flexible plastic optical fiber, to accommodate children's active lifestyles and prevent accidental breakage.

[0025] Specifically, such as Figure 1As shown, this system designs the puncture needle assembly as a replaceable module, including at least two types: adult and pediatric versions, with additional shape variations for different sites. The adult large-size needle assembly 1 basically follows the standard structure, but the pediatric small-size needle assembly 2 has been reduced in size and softened in various aspects. The pediatric needle is shorter (generally 2-4 cm depending on the child's vein depth), with a finer diameter, such as 24G, and equipped with a suitable needle hub. For the optical fiber, 50 or 62.5 micrometer core diameter fibers are used, with a total cladding diameter of approximately 125 micrometers, significantly smaller than the 200-400 micrometer fibers used in adults. The finer fiber allows for a smaller needle tube inner diameter, greatly reducing puncture trauma. To ensure the fragile fiber does not break during use, the pediatric needle tube and hub channels are straighter, avoiding sharp bends, and a certain curvature exit sheath is provided at the needle hub. The pediatric needle assembly can also adopt a soft-wing structure: that is, soft plastic wings are set on both sides of the needle hub for application and fixation to the scalp or limbs, preventing needle displacement after successful puncture. Both adult and children's needle assemblies connect to the host fiber optic cable via a unified interface (such as a screw thread or quick-connect connector), ensuring easy replacement and reliable optical path connection.

[0026] In some embodiments, the signal processing unit is used to select and adjust the parameters of the blood oxygen saturation determination algorithm according to a preset mode. Specifically, in the pediatric mode, the pulse amplitude threshold and the lower limit of the normal range of blood oxygen saturation are reduced to adapt to the weaker peripheral perfusion and potentially lower venous blood oxygen levels in children.

[0027] Specifically, in this embodiment, the normal blood oxygenation range and pulse amplitude of children, especially infants, differ from those of adults. The signal processing unit has an adult / child mode, and parameters can be switched according to the selection. In child mode, the lower limit of the SpO2 threshold for determining venous entry is lowered. For example, if the venous blood oxygenation is 70% for adults, it may be set to 65% for children to avoid misjudging lower venous oxygenation in children as no blood vessel entry. At the same time, the pulse amplitude threshold is lowered because the peripheral pulse signal in children is weaker, and the amplitude may also be small due to the puncture site being far from the heart. By lowering the detection threshold and using gain amplification, it is ensured that the effective signal of children can be identified. The alarm threshold for arterial hyperoxia can be appropriately raised or adjusted according to the mode (because the arterial oxygenation of infants may be slightly lower, and false alarms should be avoided).

[0028] In some embodiments, the signal processing unit employs high-speed, high-gain data amplification and filtering algorithms in the child mode to extract high heart rate, low-amplitude pulse signals, while employing intelligent discrimination algorithms to avoid false signals triggered by the child's agitation and misjudgment.

[0029] Specifically, in this embodiment, in children's mode, heart rates are often as high as 120–160 beats per minute or even higher, requiring the algorithm to have sufficiently high temporal resolution. The processor increases the sampling rate from 100Hz in adult mode to over 300Hz in children's mode to obtain dense data points to capture rapid pulses. Simultaneously, an adaptive filtering algorithm is introduced to filter out significant motion artifacts that may arise due to children's lack of cooperation. For example, an accelerometer is used to detect needle movement; if vigorous movement is detected, the judgment is temporarily suspended or the criterion threshold is increased to prevent false signals. The algorithm can also incorporate AI or pattern matching methods to distinguish between genuine physiological waveforms and noise fluctuations. In summary, the software is specifically optimized for the characteristics of children's signals to improve the reliability of the judgment.

[0030] In some embodiments, such as Figure 1 As shown, the fiber optic puncture needle assembly includes a straight needle type and a butterfly needle type; the straight needle type is used for routine central venous puncture, and the butterfly needle type is used for scalp vein or superficial small vein puncture, to adapt to the operational needs of different sites. In some embodiments, the patient-adaptive structure designed for different puncture sites on the scalp and limbs includes flexible fixing wings and adjustable angle needle holders to ensure that the fiber optic puncture needle is stable and reliable when used in special sites and that patient comfort is high. In some embodiments, the fiber optic puncture needle assembly is connected to the photoelectric detection device 3 through a standardized interface, and the photoelectric detection device 3 can automatically identify the needle assembly type or manually set the corresponding mode through a mode selection switch.

[0031] Specifically, in this embodiment, to adapt to different clinical scenarios, the present invention provides various forms of puncture needle components. For example, for scalp veins, the system provides a butterfly-shaped fiber optic puncture needle, which has a short needle tip and soft wings for easy fixation on the infant's scalp. Once successfully inserted, the wings can be fixed with adhesive tape to prevent slippage, while the fiber optic cable is led out through the wings to reduce traction. For superficial veins of the limbs, small straight needles or indwelling needle-type fiber optic puncture needles are provided, with the fiber optic cable combined with an indwelling tubing for both monitoring and placement. For adult central veins, conventional long needle components continue to be used. Different needle components are connected to the photoelectric detection device 3 through a standard interface. The photoelectric detection device 3 can automatically identify the components (e.g., by embedding an identification chip in the connector or using different resistance values ​​for the photoelectric detection device to determine), or the operator can select the corresponding mode on the device interface. In this way, a single system can cover a wide range of applications from neonatal scalp veins to adult deep veins, truly achieving "one machine for multiple uses".

[0032] In some embodiments, the fiber optic sensor front end of the pediatric small-sized needle assembly 2 is encapsulated with an added fiber end face reflective film or microlens to enhance the signal and improve the light signal acquisition efficiency in microvascular vessels.

[0033] Specifically, in this embodiment, to address the issue of weak signals from tiny blood vessels in children, subtle improvements were made to the fiber optic front-end sensor. One approach is to coat the fiber end with an antireflective or reflective coating to improve the collection efficiency of weak reflected light. For example, a micromirror surface can be formed by obliquely grinding the fiber end, making it easier for the emitted light to couple back to another fiber or the reflection mode of the same fiber after reflection in the blood. This may be more effective for light obtained within the extremely small blood vessels of children. Alternatively, a microlens can be attached to the fiber end to converge the diverging beam and increase the penetration depth. However, considering the size of the end, these processes require precise fabrication. For disposable products, coating is a more economical and feasible option.

[0034] In some embodiments, when a child mode is detected, the photoelectric detection device increases the LED driving current to increase the emitted light intensity.

[0035] Specifically, in this embodiment, the light source within the photoelectric detection device 3 can adjust its driving intensity according to different modes. In child mode, the LED driving current is appropriately increased to enhance the emitted light intensity, compensating for the potentially low transmittance of the thin optical fiber. Simultaneously, the photoelectric detector section uses low-noise, high-sensitivity devices, and a high-gain amplification circuit is activated in child mode. The host's analog front-end circuit can be designed with dual modes: adult mode to prevent saturation under strong signal conditions, and child mode to focus on amplifying weak signals. When switching modes, the circuit gain and light source power are changed via relays or electronic switches. The signal output to the A / D converter remains within a reasonable range in both modes to fully utilize the resolution. For example, the total gain in adult mode is x1, while the total gain in child mode is x5-x10 times, and the light source brightness is increased by approximately 50%.

[0036] Specifically, such as Figure 1 As shown, the photoelectric detection device 3 has a knob 4 on its panel, which can select "Adult Mode" or "Child Mode". In the advanced version of the automatic needle identification component, the host will automatically switch modes after connecting the needle component by reading the identification code built into the interface, without manual intervention. After entering child mode, the system loads a set of preset parameters: such as adjusting the SpO2 determination threshold range from approximately 70%-95% for adults to approximately 60%-90% for children (considering that neonatal venous oxygen may be as low as around 60%); reducing the pulse amplitude determination threshold, for example, the original requirement for AC amplitude to reach 50% of a certain benchmark is reduced to 20% in child mode; and changing the heart rate range for filtering from 30-180 beats / min to 60-220 beats / min to cover possible high-frequency heart rates.

[0037] In child mode, the ADC sampling rate is increased to, for example, 500 Hz, and the high-pass filter cutoff frequency is set to around 0.8 Hz (corresponding to 40 bpm) to remove extremely low-frequency drift. Simultaneously, because children have faster heart rates, the analysis window is shortened; for example, a 2-second window can detect 2-3 heartbeats, eliminating the need for the 4-second window required for adults. While improving real-time performance, noise prevention is crucial. Adaptive filters can be used: the acquired signal is correlated with a reference signal (such as a reference optical path or motion sensor) to eliminate common spurious signal components. For example, using a dual-axis accelerometer to monitor needle movement, when the movement is severe, the algorithm temporarily refrains from updating its judgment, waiting for the movement to decrease or for the algorithm to subtract the signal offset caused by the movement.

[0038] For highly irregular signals, machine learning models can be introduced. For example, a classification model can be pre-trained, taking the characteristics of the current signal waveform (pulse frequency, amplitude, SpO2 stability, etc.) as input and outputting whether it is "entered a blood vessel," "not entered," or "suspected artery." This can integrate multiple factors, especially in pediatric mode, to avoid missed detections. For instance, the model might learn that: although SpO2 is only 60%, a steady increase with synchronous fluctuations likely indicates recent venous entry, and since the child's oxygen levels are low, it should be judged as entered rather than not entered; or, in children with cyanotic congenital heart disease (arterial oxygen saturation may be around 60%), although SpO2 is only 60%, a steady increase with strong synchronous fluctuations suggests mistaken entry into an artery. This intelligent interpretation can further improve sensitivity.

[0039] For scalp vein puncture in infants, this invention provides a butterfly-wing fiber optic needle assembly. This assembly has an extremely short needle tube (e.g., 20-25mm), facilitating superficial vein puncture, and the needle hub features soft, flexible wings for easy fixation. In use, the mode is set to pediatric mode. After inserting the needle into the scalp vein, entry can be immediately confirmed via optical signals. Upon successful insertion, the butterfly wings prevent needle displacement, allowing for confident execution of the next procedure (e.g., indwelling catheter placement). If indwelling is required, this invention can also design the outer needle tube as a miniature cannula. After successful puncture, the inner core fiber optic needle core is removed, leaving an extremely thin tube in the vein (similar to the principle of an indwelling needle), thus eliminating the need for further punctures for infant intravenous infusion.

[0040] For small peripheral veins in school-aged children or adults, such as those on the back of the hand or foot, the small needle components of this system are also suitable. In many cases, children experience peripheral vasospasm due to fear; this system can help locate the true insertion point, reducing repeated probing. Doctors and nurses can rely on fiber optic signals to confirm needle insertion in difficult vein situations, instead of constantly trying to find blood return. Furthermore, this system is also helpful for deep veins, such as those in obese patients—although this is not relevant to children, it demonstrates its versatility across multiple sites and populations.

[0041] Besides children, the system's multi-site capabilities can also be utilized in specific adult scenarios. For example, in situations requiring catheter placement in the femoral vein, dorsal foot vein, or other similar locations, the appropriate needle component can be selected based on the vessel diameter. Furthermore, in field or combat environments, the use of different needle components allows for flexible adaptation to varying casualties and vascular conditions, thereby improving the success rate.

[0042] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A fiber optic-assisted system for pediatric and multi-site vascular puncture, characterized in that, Includes fiber optic puncture needle assembly, photoelectric detection device and signal processing unit; The fiber optic puncture needle assembly has a replaceable large-size needle assembly for adults and a small-size needle assembly for children; The photoelectric detection device has an adjustable signal judgment threshold and mode selection function, so as to select the corresponding detection parameters according to the specifications of the connected needle assembly.

2. The fiber optic-assisted system for pediatric and multi-site vascular puncture as described in claim 1, characterized in that, The fiber diameter in the pediatric small-sized needle assembly ranges from 50 to 100 micrometers, and the needle tube size ranges from 24G to 26G, in order to reduce puncture damage to children's blood vessels.

3. The fiber optic-assisted system for pediatric and multi-site vascular puncture as described in claim 1, characterized in that, The signal processing unit is used to select and adjust the parameters of the blood oxygen saturation determination algorithm according to the preset mode. Specifically, in the pediatric mode, the pulse amplitude threshold and the lower limit of the normal range of blood oxygen saturation are reduced to adapt to the weaker peripheral perfusion and potentially lower venous blood oxygen levels in children.

4. The fiber optic-assisted system for pediatric and multi-site vascular puncture as described in claim 3, characterized in that, The signal processing unit employs high-speed, high-gain data amplification and filtering algorithms in the child mode to extract high heart rate, low-amplitude pulse signals, while using intelligent discrimination algorithms to avoid false signals triggered by the child's agitation and misjudgment.

5. The fiber optic-assisted system for pediatric and multi-site vascular puncture as described in claim 4, characterized in that, The signal processing unit is further configured to: Based on the shaking signal of the needle assembly, if it exceeds the preset threshold, the determination of the puncture site of the needle assembly will be temporarily suspended or the criterion threshold of the target puncture site will be increased to prevent false signals.

6. The fiber optic-assisted system for pediatric and multi-site vascular puncture according to any one of claims 1 to 5, characterized in that, The fiber optic puncture needle assembly includes straight needle type and butterfly wing needle type; The straight needle type is used for routine central venous puncture, while the butterfly needle type is used for scalp vein or superficial small vein puncture, to meet the operational needs of different sites.

7. The fiber optic-assisted system for pediatric and multi-site vascular puncture as described in claim 6, characterized in that, The patient-adaptive structure designed for different puncture sites on the scalp and limbs includes flexible fixation wings and adjustable angle needle holders to ensure that the fiber optic puncture needle is stable and reliable when used in special sites and that patients are highly comfortable.

8. The fiber optic-assisted system for pediatric and multi-site vascular puncture according to any one of claims 1 to 5, characterized in that, The fiber optic puncture needle assembly is connected to the photoelectric detection device via a standardized interface, and the photoelectric detection device can automatically identify the needle assembly type or manually set the corresponding mode via a mode selection switch.

9. The fiber optic-assisted system for pediatric and multi-site vascular puncture as described in claim 8, characterized in that, When the child mode is detected, the photoelectric detection device increases the LED driving current, thereby increasing the emitted light intensity.

10. The fiber optic-assisted system for pediatric and multi-site vascular puncture according to any one of claims 1 to 5, characterized in that, The fiber optic sensor front end of the small-sized needle assembly for children is encapsulated with an added fiber end face reflective film or microlens to enhance the signal and improve the efficiency of light signal acquisition in tiny blood vessels.

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